Z-0947-2022 Class II Ongoing
FDA device recall Z-0947-2022 was initiated by Matrix Medical Network on January 24, 2022 and is designated Class II. Reason for recall: Due to COVID-19 Test not being authorized for home sample collection. The recall status is ongoing. Affected quantity: 3,226 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- January 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,226 kits
Product Description
Matrix Clinical Solution At-Home COVID-19 Test
Reason for Recall
Due to COVID-19 Test not being authorized for home sample collection.
Distribution Pattern
U.S.: AL, AZ, CA, CO, CT, DC, DE, FL, GA, LA, MA, MD, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, and WV. O.U.S.: N/A
Code Information
Product Number SKU: 15206 All Test Kits No Lot Numbers